Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908270
• Other study ID #: 13-5421-BO
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: July 30, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Breast cancer (Stage I-III)

• After completion of surgical therapy

• After completion of adjuvant radiotherapy and chemotherapy

• Score of 5 or greater on the Menopausal Rating Scale

• Physical and cognitive capacity to participate in the yoga intervention

• Willingness to participate in 10 or more of the 12 yoga interventions

• signed informed consent

Exclusion Criteria:

• Regular yoga practice in the past 12 months

• Planned surgery in the study period

• Diagnosed and medically treated psychosis

• Hormone replacement therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Menopause

Intervention

Behavioral:
• Yoga

Other:
• Usual care

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appraisal of body	Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)	Week 12	No
Other	Appraisal of body	Fragebogen zur Beurteilung des Körpers (Questionnaire for the assessment of body)	Week 24	No
Other	Body awareness	Body Awareness Questionnaire	Week 12	No
Other	Body awareness	Body Awareness Questionnaire	Week 24	No
Other	Self-esteem	Self-esteem scale	Week 12	No
Other	Self-esteem	Self-esteem scale	Week 24	No
Other	Adherence	Course adherence and daily home practice	Week 12	No
Other	Adherence	Daily home practice	Week 24	No
Primary	Menopausal symptoms	Menopause Rating Scale	Week 12	No
Secondary	Health-related quality of life (disease-specific)	Functional Assessment of Cancer Therapy - Breast	Week 12	No
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy - Fatigue	Week 12	No
Secondary	Anxiety	Hospital Anxiety and Depression Scale	Week 12	No
Secondary	Depression	Hospital Anxiety and Depression Scale	Week 12	No
Secondary	Menopausal symptoms	Menopause Rating Scale	Week 24	No
Secondary	Health-related quality of life (disease-specific)	Functional Assessment of Cancer Therapy - Breast	Week 24	No
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy - Fatigue	Week 24	No
Secondary	Anxiety	Hospital Anxiety and Depression Scale	Week 24	No
Secondary	Depression	Hospital Anxiety and Depression Scale	Week 24	No
Secondary	Adverse events		Week 12	Yes
Secondary	Adverse events		Week 24	Yes